Data shouldn't be a liability. I bring sanity, compliance, and readiness to your Biopharma data systems—transforming complex assets into clear advantages. Give your team the data foundation and tools they need to drive success.
A single batch leaves a trail across LIMS, QMS, MES and ERP — plus the spreadsheets, PDFs and inboxes in between. None of it was built to talk to the rest. So when you need a coherent picture, you don't analyze. You chase: across systems, across people, across versions you're not sure you can trust.
That's why a deviation investigation takes hours before anyone reaches the actual root cause. Most of that time is spent locating, formatting and reconciling data — not reasoning about what went wrong.
It's also why inspection readiness becomes a recurring fire drill. The evidence exists; proving it's complete, attributable and contemporaneous on demand is the hard part. When the foundation is fragmented, every downstream decision inherits the doubt.
None of this is a tooling problem you can buy your way out of. It's first a strategy, governance and execution problem — getting the right data into the right shape, kept compliant, and trusted across CMC and supply chain. From there, once the foundation is set, agentic AI can be a top value-driver of efficiency, automation and a reasoning-partner for every employee. I can help you get there by providing strategy, management and implementation in both the data foundation and the AI system.
System mapping, governance and gap analysis, turned into a roadmap that sequences the highest-value fixes first.
Master data management, integration and automation eliminates 'seek-and-search' data aggregation.
21 CFR Part 11, ALCOA+, validation support and Continued Process Verification — designed in from the start, not bolted on.
For teams ready for it: agentic workflow automation on top of the connected foundation, with the adoption support to make it stick.
A connected, governed foundation isn't just tidy — it's what lets modern tools work. I build and validate working agentic AI demos in real CMC workflows, including a deviation investigation taken from hours to about ten minutes. The AI is the return on fixing the data — not a substitute for it.
See the working demos on LinkedIn →Kyle Langham has spent roughly two decades building and governing data systems in the biopharmaceutical industry — with leadership work spanning CMC, supply chain, IT, PMO and clinical, across business intelligence, compliance and large-scale data integration.
A focused engagement that maps your data landscape, surfaces the compliance and sprawl risks, and names the single highest-ROI fix to start with. Low commitment, concrete output, and a clear view of what a trustworthy foundation would take.
Embedded, senior data leadership without a full-time hire. I execute the roadmap, build the connected foundation, and keep it compliant, at the pace your validation and change-control reality allows.
Pricing is scoped to the engagement, not pulled off a menu. The diagnostic is deliberately low-risk so you can judge the work before committing to more.
A 30-minute call is enough to find the first fix worth making.
Book a 30-minute call →